NL1043447B1

NL1043447B1 - Spray Device

Info

Publication number: NL1043447B1
Application number: NL1043447A
Authority: NL
Inventors: Alexander Van Barneveld Marcus; Van Geffen Geert-Jan; Bruhn Jorgen
Original assignee: Medspray Anesthesia B V; Medspray B V
Priority date: 2019-11-04
Filing date: 2019-11-04
Publication date: 2021-07-19
Also published as: US20220379047A1; EP4054682A1; WO2021090209A9; WO2021090209A1

Abstract

A spray device comprises a mouth piece that accommodates a spray nozzle unit. The spray nozzle unit is operatively connected to a liquid reservoir to receive a pressurized liquid to be sprayed. A connection between the spray nozzle unit and the liquid reservoir is effected by a flexible tube that connects at one end substantially fixedly to the mouth piece in fluid communication with the spray nozzle device. The liquid reservoir is interchangeably coupled to the opposite end of the flexible tube and, preferably, comprises a standard syringe.

Description

Spray Device The present invention relates to a spray device for oral administration of a therapeutic, in particular pharmaceutical, active agent, comprising a mouthpiece intended and adapted to be received orally by a user, which mouthpiece is provided with a spray unit which is coupled to a liquid connection and configured and adapted to receive a liquid to be sprayed therefrom under increased pressure and to release a spray of said liquid into said mouth piece, which liquid contains the active agent and is held in a liquid reservoir.

The present invention particularly relates to a disposable fine mist spray device for topical anaesthetic drug delivery to the patient's mouth and throat. The device is used to increase patient comfort in preparation for an intubation, a bronchoscopy or an upper-gastroscopy.

To that end a spraying device of the type described in the opening paragraph, according to the invention is characterized in that said mouth piece and said liquid reservoir are spatially separated from each other, in that the liquid connection comprises a flexible fluid line extending between said liquid reservoir and said, in that the fluid line at a first end maintains a substantially fixed connection to the spray unit, and in that the liquid reservoir is manually detachably coupled to a second end of the fluid line, particularly by means of a manually disconnectable coupling, more particularly a Luer coupling.

The device according to the invention particularly may be a disposable device, intended for single use on a single patient only. The fluid line particularly comprises a flexible connection tube.

The device according to the invention may be: - used to deliver a controlled spray for direct coverage of mouth and throat / oral cavity and pharynx; - supplied as an empty device; a clinician chooses the medication and exact dose and volume; - indicated to be used on patients that are deemed suitable for treatment by the clinical staff; and - adaptable to commercially available Luer-lock syringes.

-2- In a preferred embodiment the spray device according to the invention is characterized in that the liquid reservoir is contained in a holder that comprises a pressure member that may manually subjected to manual force to impose a pressure increase on the liquid that is directly derivable from said manual force, said pressure member being located at a peripheral side of the holder away, particularly across, from the connection to the fluid line. Hereinafter, the invention will be described in further detail with reference to a specific embodiment and an accompanying drawing. In the drawing: Figure 1 is an exploded view of a spray device according to the invention; Figure 2 is a detailed drawing of the mouth piece of the device of figure 1; Figure 3 is a detailed drawing of a body part of the device of figure 1; Figure 4 is a detailed drawing of the connection set of the device of figure 1, with and without a spray nozzle unit and cuff member; Figure 5 is a detailed drawing of a syringe to be used with the device of figure 1, with and without a comfort flange member; and Figure 6 is a detailed drawing of the comfort flange member used with the syringe of figure 5. It is noted that the figures are drawn purely schematically and not necessarily to a same scale. In particular, certain dimensions may have been exaggerated to a more or lesser extent to aid the clarity of any features. An embodiment of the device according to the invention is shown in figure 1 and comprises an assembly of several functional parts: - Mouth piece 1, that is ergonomically shaped for targeting the controlled spray to the patient's mouth and throat; - Body part 2, for the patient to place and hold the device - Connection set : consisting of a flexible connection tube 3 with Luer-lock 17 for connecting to disposable Luer-lock syringes 4, particularly of 1 mito 3 ml size, and - Spray nozzle unit 5.

The device according to the invention may be used for drugs that are approved for oral administration, particularly with the intention of pharyngeal or respiratory (tracheal and/or pulmonary) delivery. In this embodiment the device is used with a disposable syringe, typically

-3- 1ml to 3m, that is provided with a Luer-lock connection. The syringe is filled with a 2% or 4% lidocaine solution (40mg/m!} that is intended for pharyngeal delivery. Alternatively, the device may also be used for a pharyngeal delivery of a chloroprocaïne formulation. The mouthpiece 6 is shown in figure 2 and is intended for oral insertion into an adult patients mouth. It is formed out of a transparent bio-compatible polypropylene. The patient will be asked to close their lips around the mouthpiece. This part features an internal wall with a number of holes 7 with the purpose to create a certain flow resistance. This resistance forces the patient to inhale slowly as the inhalation speed is maximized by the internal flow resistance.

The internal wall features a centre hole 8 with radially place grooves 9 along the circumference. This centre hole exposes the active region of the spray nozzle unit, while the grooves create opposite side flows that interact with the released spray droplets of the spray nozzle unit 5 with the purpose of preventing coagulation of the droplet trains that are generated by the spray nozzle unit. The mouthpiece comprises an internal fixture 10 for a sheath flow filter 11. This filter has a press fit. The internal wall has studs that define the distance between internal wall and flow filter member. The mouth piece assembly and body part shall form one solid part after assembly. Therefore a one-way-snap connection 12 was designed that connects the two product halves. The snap fit has a symmetrical design, so that it can be assembled upside down. The snap fit has a double set of snap fingers, to prevent the product to be disassembled easily. Four ribs 13 take care of the concentric alignment of the spray nozzle unit and the spray nozzle unit 5.

The sheath flow filter comprises a porous polyethylene body 11. The poreous structure of the material creates a turbulent airflow from the air passing through the flow resistance wall of the mouth piece. The parts outer contour is manufactured with precision, so that it has a tight fit inside the mouth piece internal fixture. The centre hole shall fit tightly around the mouth piece flow resistance wall. The sheath flow filter is made from sintered sheet material. The sheet is cut to dimensions using a CNC cutting process. No loose particles are allowed because of this cutting process, as the final device shall be free of small particles or dust.

-4- The body part is made out of transparent polypropylene and is shown in figure 3. Body part features inside ribs 14 to prevent the mouthpiece from being compressed when in assembled state. The ribs play 14 an important role for the realisation of a one-way snap with mouth-piece assembly. The mouth piece assembly and body part shall form one solid part after assembly.

Therefore a one-way-snap connection connects the two product halves. The snap fit has a symmetrical design, so that it can be assembled upside down. The snap fit has a double set of snap fingers, to prevent the product to be disassembled easily. The ribs 14 at the inside of the body part push the mouth piece snap fingers towards the outside when the snap is activated. This counteracts unwanted disassembly of the two product halves.

The body part serves as a back stop for the connection set assembly. This assembly is pressed in between the mouth-piece and body part with some pre-tension. This pre-tension facilitates a hard contact between the spray nozzie unit and the internal flow resistance wall at the location of the pit flow hole. The air inlets 15 have been placed in a recessed shape, making it impossible to accidentally block the airflow with the fingers. As the device is inserted in the patients mouth, the body part serves as an indicator for the depth of insertion. The patient is asked to insert the device until the teeth touch the body part rim 16. The body part is intended to be manipulated by the user (being the medical professional and the patient) as the mouth piece is intended for mouth contact by the patient only. When the patient is asked to take aspirations, the medical professional will push firmly on the syringe, thus emptying the lidocaine formulation into the patients mouth and throat. The body part has two half-moon shaped air inlets, that allow air to flow through the device. The spray nozzle unit converts this pressurized liquid into a fine mist of droplets of predetermined size mainly depending on the size of the spray orifices of the spray nozzle unit. With the aim of targeting primarily the pharyngeal region the size of the orifices is chosen such that they will release droplets having a substantially equal nominal size of between 10 and 20 micron. This size will promote the droplets to land particularly on the pharyngeal area of the throat of the patient.

-5- A connection set between the syringe, with the lidocaine formulation, and the mouth piece with the fine mist spray nozzle unit, allows the medical professional to focus on the act of pushing the syringe empty and the patient to focus on the act of inhalation through the mouth and exhaling through the nose.

The connection set is shown in figure 4 and facilitates the connection with any 1m! to 3m! syringe.

The internal diameter {ID)of the connection set is preferably approximately 1 mm.

A wider ID will cause unnecessary dead volume of the system and spillage of formulation.

A smaller ID will influence the flow resistance of the system.

A male Luer connection 17 side of the connection set connects leak free to a female Luer adapter of the spray nozzle unit.

For successful spray generation, it is important to generate a hydrostatic pressure exceeding 7 bar.

All connections withstand this pressure without any deformation or leakage.

The other end of this set is equipped with female Luer-lock connector.

The syringe has a male

Luer-lock connection that fits to this female part of the connection set.

For disconnecting a connected empty syringe, the user must apply a certain torque.

This torque is easier to generate with a fin that is provided on the connector.

A cuff member 18 is designed to snap over the male Luer tip of the connection set.

It has an internal snap feature that creates a one-way snap action.

Assembling the cuff on the connection set requires a stroke press set-up.

This groove determines the rigidity of four concentric one-way-snap ribs.

This fluidic path assembly is inserted into the body part and then pressed in the mouth-piece with some pre-tension.

The cuff part generates this pre-tension with a slight deformation of the spring finger assembly 19. This pre-tension facilitates a hard contact between the spray nozzle unit and the internal flow resistance wall at the location of the pit flow hole.

These four grooves determine the rigidity of the pre-tensioning feature, pushing the spray nozzle unit towards the pit-plane in the mouth piece.

Figure 4 shows the completely assembled connection set, comprising the cuff member 18 and spray nozzle unit 5. This set connects to the disposable syringe 4, particularly a standard 1 ml to 3 ml disposable syringe with Luer-lock connector 17 and pressure member 21. An example of a standard syringe 4 is shown in figure 5 as it is commercially available (bottom) as well as it may be used in combination with a novel comfort flange member 20 (upper). As it is required that

-6- the medical professional applies a significant force during approximately 1 minute, resulting in about 7 bar spraying pressure, only a im! to 3ml syringe is advised. Larger syringe volumes feature larger plunger diameters and hence higher required forces for the user.

The comfort flange member 20, as depicted in greater detail in figure 6, makes it easier to apply the required force to the syringe. The comfort flange has been designed to fit over most available disposable syringes, from 1 ml to 3 ml. A recess 22 with a thinner shape fits the syringe flange, so that the comfort flange is oriented correctly around the syringe. It can be shifted over the syringe after the syringe is connected to spray device. The part is packaged with the connection set in order to make it more logical for the user to shift it over the syringe after connecting the syringe to the connection set. The flange member 20 is provided with a number of groove channels 25 that can accommodate and hold in place the flexible tube 3 while being packaged with the connection set.

Although the invention is herewith described with reference to this embodiment as shown in the figures it will be appreciated that the invention is by no means limited to that embodiment. On the contrary, many more embodiments and variation to the invention are feasible to a skilled person within the scope of the present invention.

Claims

-7- Claims:

A spray device for oral administration of a therapeutic, in particular pharmaceutical, active agent, comprising a mouthpiece intended and arranged to be received orally by a user, which mouthpiece is provided with a spraying unit coupled to a liquid connection and capable and arranged to receive therefrom a liquid to be sprayed under an increased working pressure and to dispense a mist of the liquid into the nozzle, which liquid contains the active agent and is held in a liquid reservoir, characterized in that the nozzle and the liquid reservoir are spatially separated from each other, that the liquid communication comprises a flexible liquid conduit extending between the sprayer unit and the nozzle, that the liquid conduit maintains a substantially fixed connection with the spraying unit at a first end, and that the liquid reservoir extends from a holder that is manually detachable with a second end v is coupled to the liquid line, in particular through a manually breakable coupling, more in particular a Luer coupling.

A spraying device according to claim 1, characterized in that a disposable syringe provides the liquid reservoir.

Spray device as claimed in claim 1 or 2, characterized in that the liquid line comprises a flexible hose.

4. Spraying device as claimed in claim 1, 2 or 3, characterized in that the holder comprises a manipulable pressure member on a side remote from the coupling to the liquid conduit with which a pressure increase directly derived therefrom can be imposed on the liquid by exerting manual force. .